Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT04514666
Status:
UNKNOWN
Last Update Posted:
2021-04-20
First Post:
2020-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VOCs in Kidney and Liver Transplants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-17', 'studyFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volatile organic compounds in end stage liver disease', 'timeFrame': '30 days', 'description': 'to evaluate the pattern of volatile organic compounds in patients elegible for liver transplant'}, {'measure': 'Volatile organic compounds in end stage kidney disease', 'timeFrame': '30 days', 'description': 'to evaluate the pattern of volatile organic compounds in patients elegible for kidney transplant'}, {'measure': 'Volatile organic compounds after liver transplant', 'timeFrame': '1 year', 'description': 'to evaluate the pattern of volatile organic compounds able to identify the onset of chronic failure/rejection after liver transplants'}, {'measure': 'Volatile organic compounds after liver transplant', 'timeFrame': '1 year', 'description': 'to evaluate the pattern of volatile organic compounds able to identify the onset of chronic failure/rejection after kidney transplants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant Rejection', 'Kidney Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'Kidney and liver trasplants represent very challenging lifesaving and effective surgical procedures for patients with end-stage kidney and/or liver disease.\n\nChronic rejection may occur in 3 to 17% livers transplants and in 20 to 40% kidney transplants.\n\nWhile acute rejection is clearly detected due to the clinical features and laboratory tools, the early identification of chronic rejection is still challenging since the clinical features are often silents and laboratory tests become suggestive when the damage due to the rejection is almost irreversible.\n\nConsidering the recent application of the breathomic to liver and kidney disease and the difficulty in the early detection of chronic rejection after liver and kidney transplants, the analysis of the exhaled VOCs pattern could help early detection of chronic rejection allowing a prompt medical treatment.', 'detailedDescription': 'Kidney and liver trasplants represent very challenging lifesaving and effective surgical procedures for patients with end-stage kidney and/or liver disease.\n\nNowadays the short and long term success rate of kidney and liver trasplants is pretty hight. Nevertheless, transplant rejection remains one of the biggest limitations with a strong impact on patients survival.\n\nUsually acute rejection occurs within 3 months after the transplant and is the most common cause of transplant failure and the most common indication for re-transplantation .\n\nChronic rejection may occur in 3 to 17% livers transplants and in 20 to 40% kidney transplants.\n\nWhile acute rejection is clearly detected due to the clinical features and laboratory tools, the early identification of chronic rejection is still challenging since the clinical features are often silents and laboratory tests become suggestive when the damage due to the rejection is almost irreversible.\n\nChronic renal transplant rejection is the result of a gradual decrease in the kidney function that starts to become evident three months after surgery.\n\nKidney chronic rejection is, by definition, immune-mediated and generally divides into chronic active antibody-mediated rejection and chronic active T cell-mediated rejection.\n\nTransplant vasculopathy is the single most important feature of chronic renal transplant rejection and it is the direct consequence of an immune reaction that activates a cytokines cascade with a tissue fibrosis and chronic rejection.\n\nHypertension and proteinuria are the most important features of declining renal function.\n\nLaboratory tests such as serum creatinine and estimated glomerular filtration rate (eGFR)ccan help to early identify kidney allograft dysfunction. The eGFR is suggested to be a more accurate indicator and predictor of graft function and long term graft loss.\n\nHowever, a biopsy is mandatory for diagnosing chronic renal transplant rejection. C4d complement fragment deposition in the peritubular capillaries represents the marker for antibody-mediated tissue injury.\n\nAlthough the incidence of acute and chronic rejection has declined with improvement of immunosuppression regimens, chronic rejection may lead to re-transplant or death.\n\nChronic liver allograft rejection usually occurs more than 2 months after transplantation and most frequently develops after an unresolved or multiple episodes of acute rejection or indolently over a period of months to years, with few or no clinically apparent acute cellular rejection episodes.\n\nChronic rejection characterized primarily by fibrointimal hyperplasia of arteries, or obliterative arteriopathy, interstitial fibrosis and atrophy of parenchymal elements.\n\nOften the only reliable early indicator of chronic rejection is persistent and preferential elevation of γ-glutamyl transpeptidase and alkaline phosphatase, which is related to bile duct damage. In most of cases the only clinical sign is jaundice and it appears when allograft dysfunction becomes. Biliary sludging or appearance of biliary strictures, hepatic infarcts, and finally loss of hepatic synthetic function, which can manifest as coagulopathy, malnutrition, and hepatosplenomegaly are late findings presaging allograft failure. Biopsy is mandatory to assess the liver damage.\n\nBreath analysis (Breathomics) is applied widely nowadays in clinical setting in order to identify and evaluate exhaled molecular volatile compounds as expression of a metabolic derangement of the organism including chronic diseases and cancer disease.\n\nA novel approach, a breath test based on the metabolomic evaluation of the volatile organic compounds (VOCs) in the exhaled breath, has recently been developed by our group to identify patients with Colorectal cancer, showing good reliability and compliance.\n\nVOCs analysis has also been demonstrated to find an application in the diagnosis of chronic liver and kidney disease with high sensitivity and specificity.\n\nConsidering the recent application of the breathomic to liver and kidney disease and the difficulty in the early detection of chronic rejection after liver and kidney transplants, the analysis of the exhaled VOCs pattern could help early detection of chronic rejection allowing a prompt medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sex\n* Patients eligible for liver or kidney transplant\n* Written informed consent\n\nExclusion Criteria:\n\n* Acute liver failure\n* Acute liver and kidney rejection\n* HCC\n* Re-transplant\n* Pregnancy\n* IBD\n* Any psychiatric disease'}, 'identificationModule': {'nctId': 'NCT04514666', 'briefTitle': 'VOCs in Kidney and Liver Transplants', 'organization': {'class': 'NETWORK', 'fullName': 'Societa Italiana di Chirurgia ColoRettale'}, 'officialTitle': 'Exhaled Volatile Organic Compounds as Potential Predictive Biomarkers of Chronic Kidney and Liver Rejection After Transplants', 'orgStudyIdInfo': {'id': '38/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liver/kidney transplant', 'description': 'The breath of patients undergoing liver or kidney transplant will be sampled and analysed', 'interventionNames': ['Other: Breath analysis']}], 'interventions': [{'name': 'Breath analysis', 'type': 'OTHER', 'description': 'The breath of patients undergoing liver or kidney transplant will be sampled and volatile organic compounds will be identified', 'armGroupLabels': ['Liver/kidney transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'contacts': [{'name': 'Arcangelo F Picciariello, MD', 'role': 'CONTACT', 'email': 'arcangelopicciariello@gmail.com', 'phone': '00393492185104'}, {'name': 'Arcangelo Picciariello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept of Emergency and Organ transplantation', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'centralContacts': [{'name': 'Arcangelo Picciariello, MD', 'role': 'CONTACT', 'email': 'arcangelopicciariello@gmail.com', 'phone': '+393492185104'}], 'overallOfficials': [{'name': 'Arcangelo Picciariello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Societa Italiana di Chirurgia ColoRettale'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Societa Italiana di Chirurgia ColoRettale', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}